NCT04260633

Optimizing Aligner Wear Time and Change Frequency

Optimizing Aligner Wear Time and Change Frequency: A Single-Blind, Randomized Control Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Harvard School of Dental Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study aims to help improve individualization and optimization of clear aligner therapy through the use of new technologies in orthodontics. The study will compare 12-hour and 22-hour tray wear time and evaluate the adjunctive use of Vpro+. The study clinicians will use Dental Monitoring to monitor study participants throughout the trial and will use the Dental Monitoring system to instruct patients to continue or stay on their clear aligners. The outcome of the study will be the time it takes to complete 10 trays.

Conditions

• Adjunctive Usage of Vibrational Therapy
• Dental Monitoring Accuracy

Interventions

Type	Name	Description
DEVICE	Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial.	The current standard of care for clear aligner use as suggested by Invisalign is unclear as to how frequently aligners should be changed. We suspect that the frequency for aligner change as determined by the orthodontist using Dental Monitoring will be variable for every participant. Vpro+ is an adjunctive therapeutic tool for clear aligner treatment. It is proposed to deliver high frequency vibrations to reduce treatment time and pain associated with clear aligners. Align Technology suggests 22-hour wear time for clear aligner therapy. Participants in two arms of the study will be asked to wear the trays for about half the recommended wear time to assess whether night-time aligner wear will be sufficient for successful treatment.

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-11-01
• Completion: 2021-03-01
• First posted: 2020-02-07
• Last updated: 2020-02-17